Here is the FDA document explaining the limited approval of GSK's Horizant (new gabapentin):
https://docs.google.com/viewer?a=v&q...b-hRYGgitH9G-w
It has to do with cancer of the pancreas risk. And that parent company did not provide NEW data showing increased absorption was safe.
Quote:
They noted that the rat tumors were of pancreatic acinar cells and that such tumors occur
spontaneously in the rat, whereas the majority of human of pancreatic tumors are ductal in
origin. They also opined that the rat is uniquely sensitive to gabapentin-induced pancreatic
acinar cell tumors, possibly because of greater uptake of gabapentin into the pancreas, as
evidenced by an unusually high spontaneous rate of these tumors in rats. They also posited
that male rats are particularly sensitive to gabapentin-induced pancreatic acinar cell tumors
because of differential effects of male and female sex hormones.
The pharmacology/toxicology review team did not find these arguments to be compelling.
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The paper is long, and goes into some mathematical jargon typical of studies. But at the end they do suggest a 300mg size dose (going DOWN rather than UP), because of side effects, and suicide risk.
All in all it appear to be carefully worded to not include chronic pain patients at this time.
We'll just have to wait and see.
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All truths are easy to understand once they are discovered; the point is to discover them.-- Galileo Galilei
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Weezie looking at petunias 8.25.2017
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